Systems Engineer

What the role needs

• Collaborate with seasoned Systems Engineers on troubleshooting design issues and methods of improvement.
• Collaborate cross-functionally including but not limited to Customer Support, Product Support, Software Development, Product Management, Quality organizations
• Lead in root cause investigations, risk evaluations, and design change assessments related to on-market product issues; support seamless transition of information from the field to development and vice versa.
• Own delivery of post-market initiatives, including field investigations and quality management processes.
• Author engineering build requests with direct responsibility for managing engineering materials.
• Design and set up feasibility tests in a lab environment.
• Author design feasibility protocols and reports.
• Participate in product design, technical reviews, and triage brainstorming sessions.
• Design verification testing execution in support of design improvements, FDA and international clearance, or commercial release. Contribute to team goals by accomplishing related tasks as required
• BS in an Engineering (Biomedical, Computer Science) discipline
• At least 2 years experience as a Systems/Project Engineer in the Medical Device or other regulated industry and/or equivalent.
• Ability to work in a fast paced, dynamic environment with a passion for continuous learning

From the employer

Job Summary The Systems Engineer position is designed to provide the selected candidate with a broad exposure to the design, development, sustaining, and quality processes for wearable medical devices that are used by patients around the world daily. This position will be an integral member of the R&D team directly supporting the product development phases of Insulet’s innovation pipeline of wearable pump technology, with an emphasis on technical support within Lifecycle Engineering. This role will provide exposure to several aspects of Insulet’s design control and sustaining processes, including but not limited to failure analysis, risk assessment, troubleshooting / design analysis, interpreting and analyzing requirements, system integration, verification test methods, and design documentation. The Systems Engineer position is designed to provide the selected candidate with a broad exposure to the design, development, sustaining, and quality processes for wearable medical devices that are used by patients around the world daily. This position will be an integral member of the R&D team directly supporting the product development phases of Insulet’s innovation pipeline of wearable pump technology, with an emphasis on technical support within Lifecycle Engineering. This role will provide exposure to several aspects of Insulet’s design control and sustaining processes, including but not limited to failure analysis, risk assessment, troubleshooting / design analysis, interpreting and analyzing requirements, system integration, verification test methods, and design documentation. Responsibilities Collaborate with seasoned Systems Engineers on troubleshooting design issues and methods of improvement. Collaborate cross-functionally including but not limited to Customer Support, Product Support, Software Development, Product Management, Quality organizations Lead in root cause investigations, risk evaluations, and design change assessments related to on-market product issues; support seamless transition of information from the field to development and vice versa. Own delivery of post-market initiatives, including field investigations and quality management processes. Manage escalations and inquiries from field-facing partners related to on-market product, reporting findings to internal issue management teams when applicable. Support all phases of the design and development lifecycle of a medical device Author engineering build requests with direct responsibility for managing engineering materials. Design and set up feasibility tests in a lab environment. Author design feasibility protocols and reports. Participate in product design, technical reviews, and triage brainstorming sessions. Design verification testing execution in support of design improvements, FDA and international clearance, or commercial release. Contribute to team goals by accomplishing related tasks as required Basic Qualifications: BS in an Engineering (Biomedical, Computer Science) discipline At least 2 years experience as a Systems/Project Engineer in the Medical Device or other regulated industry and/or equivalent. Ability to work in a fast paced, dynamic environment with a passion for continuous learning Passionate about improving the lives of others Technical writing ability Experience with lab equipment (testing) Microsoft office suite (Word, Excel, PowerPoint) Effective communication skills Preferred Skills and Competencies: Experience with Software as a Medical Device (SaMD) preferred. Demonstrated working knowledge of engineering principles and scientific methods. Strong systems-thinking and structured problem-solving skills. Experience troubleshooting complex systems consisting of interacting hardware, software, mobile, cloud, connectivity, and/or third-party components. Experience analyzing diagnostic logs, telemetry, system events, or large technical datasets. Working knowledge of cloud systems, mobile technologies, APIs, wireless communications, and connected/IoT (Internet of Things) systems; a strong plus. Experience with Amazon Web Services (AWS), Microsoft Azure; a strong plus. General understanding of medical device risk and issue management; a strong plus. Experience with software / product lifecycle tools – Jira, Helix, Bamboo, Bitbucket, Polarion; a strong plus. Hands-on and inquisitive, not being afraid to challenge a design. General understanding of medical devices & regulations. Experience with data analysis (MatLAB, Minitab, PowerBI, or similar analytical tools). Planning and organization skills. Ability to organize and judge priorities in a dynamic environment. Physical Requirements (if applicable): Must be able to sit or stand for 8 hours a day Additional Information: Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $81,700.00 - $122,500.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education. Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com. We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it! At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. ( Know Your Rights )